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To investigate the correlation and agreement between the intraocular pressure peaks detected during the water drinking test and modified diurnal tension curve in glaucomatous eyes and to analyse whether this is associated with prognostic outcome. The study will also measure autonomic nervous system activation during the test to investigate one possible mechanism behind it.
Glaucoma is a progressive optic neuropathy characterized by progressive loss of retinal ganglion cells, leading to thinning of the retinal nerve fiber layer and visual field losses. It is the leading cause of irreversible blindness in the world [2] and affects more than 70 million people worldwide. Intraocular pressure (IOP) is the main risk factor for the development and progression of glaucoma. The gold standard for intraocular pressure (IOP) measurement is applanation tonometry. Routine office measurements may not detect IOP peaks in roughly 30% of patients due to variation throughout the day and this detection failure may be responsible for visual field progression in apparently well-controlled patients. Therefore this study is to investigate the correlation and agreement between the intraocular pressure peaks detected during the water drinking test and modified diurnal tension curve in glaucomatous eyes and to analyze whether this is associated with prognostic outcome. The study will also measure autonomic nervous system activation during the test to investigate one possible mechanism behind it. The primary measure is peak Intraocular pressure measurements from two different measures. Secondary measures include OCT angiography, postural blood pressure, heart rate, pupil diameter. Current and future rates of progression using visual field and optical coherence tomography (OCT) measures. This is a prospective method comparison study, of 40 primary open angle and normal tension glaucoma patients who will attend for a single visit. Inclusion criteria include those
Following completion of the study, participants will be followed up in their usual clinic as part of their regular care. The participants' follow-up data which is routinely generated as part of the glaucoma care pathway will be accessed for 18 months following completion of participation with a view of correlating initial results with possible disease progression and other related outcomes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Diurnal Tension Curve | Diagnostic Test | The modified diurnal tension curve (mDTC), an alternative that involves IOP measurements every 2 or 3 hours during office hours, is more feasible and may provide better information regarding the IOP profile than single IOP measurements. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Intraocular Pressure Difference (Between mDCT and WDT) | Maximum intraocular pressure difference between two methods applied to each subject (modified diurnal tension curve mDTC and water drinking test WDT). The difference between maximum intraocular pressure of five eye pressure measurements taken at 8:00, 10:00, 12:00, 14:00 and 16:00 minus the maximum intraocular pressure measured at 15 minute intervals over 45 minutes during the water drinking test. | Single measurement (mDCT 5 measurements taken one every 2 hours and WDT a measurement taken every 15 minutes up to 45 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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Primary open-angle and normal tension glaucoma patients
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| Name | Affiliation | Role |
|---|---|---|
| Francesca Cordeiro | Imperial College Healthcare NHS Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Ophthalmic Research Group | London | NW1 5QH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38454171 | Result | Yap TE, Gao Y, Ahmad H, Susanna F, Susanna R, Normando EM, Bloom PA, Cordeiro MF. Comparison of intraocular pressure profiles during the water drinking test and the modified diurnal tension curve. Eye (Lond). 2024 Jun;38(8):1567-1574. doi: 10.1038/s41433-024-02954-0. Epub 2024 Mar 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Glaucoma Patients | Those included in the study were male or female participants between the ages of 18 to 80 years old with a diagnosis of POAG or NTG in either eye. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glaucoma Patients | Those included in the study were male or female participants between the ages of 18 to 80 years old with a diagnosis of POAG or NTG in either eye. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Intraocular Pressure Difference (Between mDCT and WDT) | Maximum intraocular pressure difference between two methods applied to each subject (modified diurnal tension curve mDTC and water drinking test WDT). The difference between maximum intraocular pressure of five eye pressure measurements taken at 8:00, 10:00, 12:00, 14:00 and 16:00 minus the maximum intraocular pressure measured at 15 minute intervals over 45 minutes during the water drinking test. | Posted | Mean | Standard Deviation | mmHg | Single measurement (mDCT 5 measurements taken one every 2 hours and WDT a measurement taken every 15 minutes up to 45 minutes) |
|
2.5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glaucoma Patients | Those included in the study were male or female participants between the ages of 18 to 80 years old with a diagnosis of POAG or NTG in either eye. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Spofforth | Imperial College Ophthalmology Research Group | 020 3312 6666 | Jamiespofforth@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 14, 2020 | Aug 12, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D057066 | Low Tension Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D009901 | Optic Nerve Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mean baseline IOP (± SD) | IOP (intraocular pressure) | Mean | Standard Deviation | mmHg |
|
| Mean visual field mean deviation | Measurement of the light intensity used to test (Decibels) Normally the more negative this number is the more severe is the condition. | Mean | Standard Deviation | dB |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
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